Defining Conflict of Interest - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Defining Conflict of Interest
The divide between innovation and conflict of interest in medical research is not so clear.


Pharmaceutical Technology
Volume 36, Issue 3, pp. 38

What is a conflict of interest? Gilbert's Law Dictionary says that a conflict of interest (COI) arises when private interests clash with one's duty to serve the public interest. Prejudicial interest refers to having an interest in a topic that may affect one's ability to fairly and objectively consider the subject. Equipoise is a scientific concept by which a researcher believes in a hypothesis, yet no factual proof yet exists. Equipoise becomes conflict when medical professionals convince themselves they are right despite evidence to the contrary because of their own self-interests. When that happens, an ethical line in the sand is crossed. It can be hard to tell when that line gets crossed, no matter how rigorously a decision, affiliation, or financial arrangement is examined.

There are a panoply of new standards, rules, and guidelines relating to COI for medical research. The Physician Payment Sunshine provisions under the Patient Protection and Affordable Care Act mandate medical product and device companies to report any kind of transfer of value to physicians and post it in a public database. A half dozen states, with more likely to follow, have rules governing conduct for pharmaceutical and medical-device manufacturers that require reporting, prohibit, or impose restrictions on a wide array of physician–industry activities ranging from free meals to continuing medical education courses. At the federal level, rules under the National Institutes of Health (NIH) require medical researchers receiving federal grants to disclose any industry payments over $5000 and allow a university's NIH grants to be withdrawn for egregious violations or lack of oversight.

In the private sector, medical researchers are required by some medical publications to fill out standardized forms that enumerate payments from consulting work, honoraria, expert testimony, grants, commissioned manuscripts, intellectual property rights, royalties, stock holdings, and advisory boards. The American Medical Students Association ranks medical schools annually based on their COI polices, and the Pew Prescription Project and Yale University both have conducted recent surveys of patient attitudes regarding physician ties to pharmaceutical companies.

Why the brouhaha? In part, it is because of the media's attention to this type of story. A recent example reported in MedPage Today concerned Thomas Zdeblick, chair of the Department of Orthopedics at the University of Wisconsin–Madison, which according to the article, received more than $25 million in royalties since 2003 from Medtronic, a firm that sells spinal devices. Reportedly, this funding occurred while the hospital affiliated with the university spent $27 million on Medtronic spinal products from 2004–2010. Zdeblick also received more than $1 million in compensation from the university in 2010, according to the article (1).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here